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Nitinotes secures CE mark for automated suturing platform ‘EndoZip’
Digitisation | November 11, 2025

Nitinotes secures CE mark for automated suturing platform ‘EndoZip’

Enabling a new era in minimally invasive obesity treatment across Europe


Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer
Clinical Trials | November 10, 2025

Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026


Novo Nordisk presents four new analyses on oral semaglutide 25 mg at ObesityWeek 2025
Clinical Trials | November 06, 2025

Novo Nordisk presents four new analyses on oral semaglutide 25 mg at ObesityWeek 2025

Oral semaglutide 25 mg was associated with the same weight loss efficacy in women with obesity regardless of menopausal stage, and patients reported improvements in physical function, respectively


Sumitomo Pharma America unveils promising new leukemia and myelofibrosis data ahead of ASH 2025
Clinical Trials | November 06, 2025

Sumitomo Pharma America unveils promising new leukemia and myelofibrosis data ahead of ASH 2025

Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis


Teva reports 11th consecutive quarter of growth
News | November 06, 2025

Teva reports 11th consecutive quarter of growth

Teva reported third quarter revenues of $4.5 billion, an increase of 3 per cent year-over-year.


FDA issues warning letter to Philips over manufacturing and quality system deficiencies
Medical Device | October 31, 2025

FDA issues warning letter to Philips over manufacturing and quality system deficiencies

The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days


Aldeyra refocuses pipeline on next-gen RASP modulators despite positive phase II success
Clinical Trials | October 31, 2025

Aldeyra refocuses pipeline on next-gen RASP modulators despite positive phase II success

ADX-248, which replaces ADX-743, is being developed for the treatment of metabolic inflammation, including obesity and hypertriglyceridemia


AskBio’s gene therapy shows promising 12-month results for heart failure
Biotech | October 29, 2025

AskBio’s gene therapy shows promising 12-month results for heart failure

Results demonstrate favorable safety profile and clinically meaningful improvements in patients with non-ischemic heart failure


FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma
Drug Approval | October 29, 2025

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability


Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study
Clinical Trials | October 25, 2025

Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study

Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy